CompletedNCT05044793Updated Jan 22, 2025Results posted

A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System

An observational study in Glaucoma, Open-Angle, sponsored by Sight Sciences, Inc.. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Sight Sciences, Inc. · Observational

Study type: Observational
Model: Other
Time perspective: Other
Enrollment: 70
Sex: All

Study summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213

Conditions studied

Glaucoma, Open-Angle

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Glaucoma, Open-Angle 943

In context

Glaucoma, Open-Angle

943 studies on the registry are indexed under Glaucoma, Open-Angle; 118 are open to participants now.

This study's enrollment of 70 is below the median of 100 across 185 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Sight Sciences, Inc. is the lead sponsor of 17 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Participants who received treatment and completed Protocol #06213

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participated in, received treatment, and completed Protocol #06213

Exclusion criteria

Exclusion Criteria:

Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits
Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)

Study design

Observational model: Other
Time perspective: Other
Enrollment: 70 participants (actual)
Patient registry: No

Groups and cohorts

Cohort A
Subjects who had a surgical washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.
Device: OMNI® Surgical System
Cohort B
Subjects without a surgical washout of ocular hypotensive medications with pre-surgical medicated IOP≥18 mmHg and on 1 to 5hypotensive medications and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.
Device: OMNI® Surgical System

Interventions

DeviceOMNI® Surgical System
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

What researchers measure

Primary outcomes

Primary Safety Endpoint
Rate of occurrence of sight-threatening adverse events
Time frame: 12 months

Other outcomes

Change in Intraocular Pressure (IOP)
Mean change in IOP
Time frame: 12 months
Change in Hypotensive Medications
Reduction in number of hypotensive medications from baseline to 36 months
Time frame: 12 months
Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months
For subjects in cohort A : ≥20% reduction in unmedicated diurnal IOP from baseline to 36 months For subjects in cohort B: ≥20% reduction in mean medicated IOP from baseline to 36 months
Time frame: 12 months
Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.
For cohort A: unmedicated diurnal IOP between 6 and 18 mmHg inclusive For cohort B: medicated IOP between 6 and 18 mmHg inclusive
Time frame: 12 months

Results

Posted Jan 22, 2025

Participant flow

Participant flow — Overall Study
Milestone	Cohort A	Cohort B
Started	66	4
Completed	66	4
Not completed	0	0

Outcome measures

PrimaryPrimary Safety Endpoint

Rate of occurrence of sight-threatening adverse events

Time frame:: 12 months
Reported as:: Mean · adverse event

Primary Safety Endpoint
adverse event	Cohort A	Cohort B
Primary Safety Endpoint	0 ± 0	0 ± 0

Other pre-specifiedChange in Intraocular Pressure (IOP)

Mean change in IOP

Time frame:: 12 months
Reported as:: Mean · mmHg

Change in Intraocular Pressure (IOP)
mmHg	Cohort A	Cohort B
Change in Intraocular Pressure (IOP)	-6.89 ± 3.42	-11.00 ± 16.45

Other pre-specifiedChange in Hypotensive Medications

Reduction in number of hypotensive medications from baseline to 36 months

Time frame:: 12 months
Reported as:: Mean · number of medications

Change in Hypotensive Medications
number of medications	Cohort A	Cohort B
Change in Hypotensive Medications	-1.2 ± 0.87	-1.0 ± 1.00

Other pre-specifiedNumber of Participants With ≥20% Reduction in IOP From Baseline to 36 Months

For subjects in cohort A : ≥20% reduction in unmedicated diurnal IOP from baseline to 36 months For subjects in cohort B: ≥20% reduction in mean medicated IOP from baseline to 36 months

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months
Participants	Cohort A	Cohort B
Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months	45	1

Other pre-specifiedNumber of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.

For cohort A: unmedicated diurnal IOP between 6 and 18 mmHg inclusive For cohort B: medicated IOP between 6 and 18 mmHg inclusive

Time frame:: 12 months
Reported as:: Count of participants · Participants

Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.
Participants	Cohort A	Cohort B
Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.	41	2

Adverse events

Collected over 36 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort A	0/66 (0%)	1/66 (1.5%)	27/66 (40.9%)
Cohort B	0/4 (0%)	0/4 (0%)	2/4 (50%)

Most frequent serious events

Most frequent serious events
Event	Cohort A	Cohort B
Adverse eventsMusculoskeletal and connective tissue disorders	1/66	0/4

Most frequent other events

Most frequent other events
Event	Cohort A	Cohort B
Ocular adverse eventsEye disorders	27/66	2/4

Baseline characteristics

The Intent-to-Treat (ITT) analysis population included all subjects who were enrolled and treated, regardless of whether or not they had a protocol deviation

Age, Categorical
Age, Categorical(Participants)	Cohort A	Cohort B	Total
<=18 years	0	0	0
Between 18 and 65 years	13	1	14
>=65 years	53	3	56

Age, Continuous
Age, Continuous(years)	Cohort A	Cohort B	Total
Mean	71.6 ± 7.5	68.0 ± 14.1	71.4 ± 7.9

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort A	Cohort B	Total
Female	36	2	38
Male	30	2	32

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort A	Cohort B	Total
Hispanic or Latino	22	1	23
Not Hispanic or Latino	44	3	47
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort A	Cohort B	Total
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	6	0	6
White	59	4	63
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Cohort A	Cohort B	Total
United States	66	4	70

Study locations

4 sites

Grene Vision Group
Wichita, Kansas 62708, United States
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma 73112, United States
Northern Ophthalmics
Jenkintown, Pennsylvania 19406, United States
El Paso Eye Surgeons
El Paso, Texas 79902, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 18, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2021 to primary completion in Aug 2023, 23 months.

Results were first posted in Jan 2025, 1 year 5 months after primary completion.

Of 56 observational studies under Glaucoma, Open-Angle, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12. This study's 23 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 9, 2021
First posted: Sep 16, 2021
StartActual: Sep 1, 2021
Primary completionActual: Aug 21, 2023
CompletionActual: Aug 21, 2023
Results first posted: Jan 22, 2025
Last update: Jan 22, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05044793
Lead sponsor: Sight Sciences, Inc.
Responsible party: Sponsor
First posted: Sep 16, 2021
Start date: Sep 1, 2021
Primary completion: Aug 21, 2023
Completion: Aug 21, 2023
Results posted: Jan 22, 2025
Last update: Jan 22, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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